FDA recall Z-2068-2026

Product

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

Reason for recall

If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.

Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

Key facts

Status

Ongoing

Initiation date

2026-01-07

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dossenheim, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2068-2026